BEUDAMED
    FDA Enforcement Class III Ongoing

    Arctic Sun ArcticGel Pads - Medium, Product Code 317-07

    Recall: Z-0590-2018 · Reported December 13, 2017

    Enforcement

    Recall Number
    Z-0590-2018
    Event ID
    77469
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    C.R. Bard, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 13, 2017
    Initiation Date
    June 2, 2017
    Classification Date
    February 12, 2018
    Address
    8195 Industrial Blvd NE, N/A, Covington, GA, 30014-1497, United States

    Description

    Arctic Sun ArcticGel Pads - Medium, Product Code 317-07

    Reason

    Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.

    Code Info

    Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.

    Distribution

    Distributed domestically. Distributed internationally to Australia and Belgium.

    Quantity

    128 units